By Kenan Machado
MUMBAI--Lupin Pharmaceuticals Inc. is recalling thousands of
bottles of one of its Indian-made antibacterial drugs after finding
that they failed to meet U.S. standards for impurities.
The Baltimore-based firm recalled close to 10,000 bottles of the
drug made by its Indian parent, Lupin Ltd., the U.S. Food and Drug
Administration said on its website. The recall was initiated on
Jan. 27 but made public by the FDA this week.
"This is a voluntary recall initiated on our own and of no
business consequence," a Lupin spokesman in India said without
elaborating
The recall is the latest embarrassing incident for Indian
pharmaceutical firms that have thrived in the lucrative market for
drugs that have gone off patent.
The U.S. FDA has in recent years increased its vigilance of
these firms as India became the second-largest supplier of generic
drugs in the U.S.
Lupin--the fifth-largest generic drug maker in the U.S. in terms
of prescriptions--gets 40% of its net sales from the U.S.
The latest recall is for Lupin's branded drug Suprax, the brand
name for cefixime--an antibiotic used to treat bacterial infections
of the ear and upper respiratory tract.
The Indian firm, India's fourth-largest generic drug maker by
market capitalization, joins its larger peers in trying to become
more vigilant in the face of increasing regulatory scrutiny from
the U.S.
India's largest drug maker by sales, Ranbaxy Laboratories Ltd.,
had to issue a recall of generic versions of the cholesterol drug
Lipitor in the U.S. earlier this year due to a potential dose
mix-up. Previously the company had to recall about 480,000 bottles
of the popular drug after glass particles were found in some
bottles.
Sun Pharmaceutical Industries Ltd. recalled thousands of bottles
of generic diabetes medication in the U.S. this year after some
bottles were found to contain drugs meant to treat epilepsy.
Ranbaxy's majority owner, Japanese firm Daiichi Sankyo Co. just
last week agreed to sell its stake to Sun Pharma after all the
trouble with the FDA.
Write to Kenan Machado at kenan.machado@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires